Chronic fatigue syndrome (CFS) is a clinically defined condition characterized by severe disabling flu-like fatigue and a combination of symptoms that include impairment in concentration and short-term memory, sleep disturbances, and musculoskeletal pain. No specific test exists to diagnose chronic fatigue syndrome. Therefore, the presence of chronic fatigue requires a clinical evaluation to identify underlying conditions that may require treatment. A patient should be evaluated for depression and other psychiatric disorders; alcohol or other substance abuse; and current use of prescription and over-the-counter medications and food supplements. In addition, a complete laboratory work-up should be performed to rule out the possibility of any existing medical problems. The central issue is whether chronic fatigue syndrome or any subset of the syndrome is a pathologically discrete entity or a debilitating but nonspecific condition shared by many different illnesses.
The study of chronic fatigue syndrome is problematic because, to date, no tests have consistently proven or demonstrated this illness. Tests should be directed toward confirming or excluding other etiologic possibilities. Clarification of the relation between chronic fatigue syndrome and neuropsychiatric syndromes are particularly important. These latter disorders are the source of confusion in studies of chronic fatigue syndrome as these disorders are diagnosed more frequently in populations affected by chronic fatigue than in the general population. The extent to which the features of chronic fatigue syndrome are generic features of chronic fatigue and deconditioning due to physical inactivity common to a diverse group of illnesses must be established.
Fibromyalgia (FMS) is a chronic rheumatic condition characterized by systemic body pain and uncontrollable fatigue. Many other symptoms are associated with fibromyalgia, such as irritable bowel, headaches, sleep disorders, and poor circulation.
Chronic fatigue syndrome and fibromyalgia remain serious problems for the general population which are not only difficult to diagnose and have no known effective treatment. Although many medications are commonly used to treat these conditions, there are no known medications which permanently resolve the symptoms of either chronic fatigue syndrome or fibromyalgia. In addition, many of the currently used medications produce side effects ranging from mild side effects, e.g., drowsiness, dizziness, and nausea to serious side effects, e.g., addiction and liver damage.
Some of the more common medications currently employed to treat chronic fatigue syndrome and/or fibromyalgia include, but are not limited to, analgesics, hypnotics, immune suppressants, various other prescribed medications, and an array of non-prescription medications.
Analgesics include nonsteroidal anti-inflammatory drugs which can relieve pain. Some preparations of analgesics are available as over-the-counter medications and have been prescribed for CFS and fibromyalgia patients for symptomatic relief. An analgesic that is sometimes prescribed for CFS and FMS patients is cyclobenzaprine. It is generally prescribed for the relief of skeletal muscle spasm and its associated signs and symptoms.
Benzodiazepines are one commonly used type of hypnotics. This group of drugs is sometimes prescribed to treat seizures, but it is prescribed for CFS patients as a treatment for various sleep disorders. Examples of benzodiazapines used in the treatment of chronic fatigue syndrome and fibromyalgia are Klonopin.TM., Valium.TM., Zanax.TM., Ativan.TM., and Dalmane.TM.. A non-benzodiazepine hypnotic drug that has sometimes been prescribed to relieve sleep problems for CFS patients is Zolpidem..TM.
Azathioprine is an immune suppressant that has been prescribed to CFS and FMS patients. Presumably, these drugs have been employed based on the unsubstantiated theory that CFS is characterized by some underlying immune dysfunction. Such a use is purely experimental and, in view of the degree of toxicity associated with these agents, is inappropriate for the treatment of CFS and FMS.
Some of the various other prescription drugs given to treat CFS and FMS patients include Naltrexone.TM., an opioid antagonist, sodium retention agents/beta blockers, calcium channel blockers/histamine blockers, anti-depressants, allergy medications, and acute anxiety medications. Most of these drugs are either inappropriate for the treatment of CFS and FMS either because they are not effective or because of the significant side effects associated with their use.
Some of the non-prescription medications given to patients with CFS and FMS include herbal preparations, and vitamin and mineral supplements. Although the potential medicinal value of various herbs is promising, it is difficult, if not impossible, to assess the validity of scientific claims regarding these substances. In addition, vitamin/mineral supplements may demonstrate some positive results but none have any scientifically demonstrated clinical value. In addition, these supplements may be toxic if taken in high doses.
Thus, it is clear that chronic fatigue syndrome and fibromyalgia are debilitating diseases for which no known effective treatment exist. What is needed, therefore, is a composition that is effective in treating chronic fatigue syndrome and fibromyalgia. Also needed are methods for delivery which would allow for easy and regimented application.